This guidance provides answers to anticipated user-fee questions from generic drug industry participants regarding the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA. The questions and answers (Q&A) format is intended to promote transparency and facilitate compliance. The first version of this document was issued pursuant to 21 CFR 10.115 and was made available on FDA’s website on August 22, 2012. In response to comments received in the docket and to address additional questions that have arisen since the beginning of GDUFA, FDA issued Revision 1 of the draft guidance on September 10, 2013.

This guidance finalizes the user fee Q&A section of Revision 1 of the draft guidance. This final guidance document addresses comments FDA received on Revision 1, adds questions and answers that FDA and industry have discussed regarding user fees since the launch of the program, and finalizes the user fee section of the revised version of the guidance. Questions and answers related to GDUFA’s self-identification, review of generic drug submissions, and inspections and compliance provisions that appeared in draft versions of this guidance will appear in updated form in a separately issued final guidance.

This guidance is one in a series of GDUFA communications. Other communications, including similar guidances and Federal Register (FR) notices, are available at Where applicable, references to information in these communications are included in this Q&A guidance

Posted on the FDA website on 21 November 2016